Antimicrobial wipes which provide improved immediate germ reduction

ABSTRACT

The present invention relates to an antimicrobial wipe effective against Gram positive bacteria, Gram negative bacteria, fungi, yeasts, molds, and viruses comprising a porous or absorbent sheet impregnated with an antimicrobial cleansing composition, wherein the antimicrobial cleansing composition comprises from about 0.001% to about 5.0%, by weight of the antimicrobial cleansing composition, of an antimicrobial active; from about 0.05% to about 10%, by weight of the antimicrobial cleansing composition, of an anionic surfactant; from about 0.1% to about 10%, by weight of the antimicrobial cleansing composition, of a proton donating agent; and from about 3% to about 99.85%, by weight of the antimicrobial cleansing composition, water; wherein the composition is adjusted to a pH of from about 3.0 to about 6.0; wherein the antimicrobial cleansing composition an One-wash Immediate Germ Reduction Index of greater than about 1.3; and wherein the rinse-off antimicrobial cleansing composition has a Mildness Index of greater than 0.3. The present invention also relates to methods for removing germs from the skin using the antimicrobial wipes described herein.

TECHNICAL FIELD

The present invention relates to cleansing wipes comprising absorbentsheets impregnated with antimicrobial cleansing compositions. Thesecleansing wipes provide enhanced antimicrobial effectiveness compared toprior art compositions. Specifically, the cleansing wipe personalcleansing compositions of the invention provide previously unseenimmediate germ reduction.

BACKGROUND OF THE INVENTION

Human health is impacted by many microbial entities. Inoculation byviruses and bacteria cause a wide variety of sicknesses and ailments.Media attention to cases of food poisoning, strep infections, and thelike is increasing public awareness of microbial issues.

It is well known that the washing of hard surfaces, food (e.g. fruit orvegetables) and skin, especially the hands, with antimicrobial ornon-medicated soap, can remove many viruses and bacteria from the washedsurfaces. Removal of the viruses and bacteria is due to the surfactancyof the soap and the mechanical action of the wash procedure. Therefore,it is known and recommended that the people wash frequently to reducethe spread of viruses and bacteria.

Bacteria found on the skin can be divided into two groups: resident andtransient bacteria. Resident bacteria are Gram positive bacteria whichare established as permanent microcolonies on the surface and outermostlayers of the skin and play an important, helpful role in preventing thecolonization of other, more harmful bacteria and fungi.

Transient bacteria are bacteria which are not part of the normalresident flora of the skin, but can be deposited when airbornecontaminated material lands on the skin or when contaminated material isbrought into physical contact with it. Transient bacteria are typicallydivided into two subclasses: Gram positive and Gram negative. Grampositive bacteria include pathogens such as Staphylococcus aureus,Streptococcus pyogenes and Clostridium botulinum. Gram negative bacteriainclude pathogens such as Salmonella, Escherichia coli, Klebsiella,Haemophilus. Pseudomonas aeruginosa, Proteus and Shigella dysenteriae.Gram negative bacteria are generally distinguished from Gram positive byan additional protective cell membrane which generally results in theGram negative bacteria being less susceptible to topical antibacterialactives.

Antimicrobial cleansing products have been marketed in a variety offorms for some time. Forms include deodorant soaps, hard surfacecleaners, and surgical disinfectants. These traditional rinse-offantimicrobial products have been formulated to provide bacteriareduction during washing. For example, Dial® liquid soaps, when used inhand washing, have been found to reduce the amount of the bacteria onthe skin by from about 2.0 log (97%) to about 2.5 log (99.7%) in one 30second handwash, as measured by standard Health Care Personal HandwashTests (HCPHWT). That is skin washed with these soaps were contaminatedwith only 0.3%-3% of the number of bacteria compared to before washing.Antimicrobial liquid cleansers are disclosed in U.S. Pat. No. 4,847,072,Bissett et al., issued Jul. 11, 1989, U.S. Pat. No. 4,939,284,Degenhardt, issued Jul. 3, 1990 and U.S. Pat. No. 4,820,698, Degenhardt,issued Apr. 11, 1989, all of which are incorporated herein by reference.

Some of these antimicrobial products, especially the hard surfacecleaners and surgical disinfectants, utilize high levels of alcoholand/or harsh surfactants which have been shown to dry out and irritateskin tissues. Dial® bar soap has been found to provide from 2.5 to 3.0log reduction in bacteria in one wash, as measured by the HCPHWT.However, Dial® can be drying to the skin with repeated use. Hibiclens®Surgical Scrub provides 2.5 to 3.0 log reduction in germs in one wash,however it utilizes a potent cationic antibacterial agent,chlorohexidine, which has product safety concerns. Ideal personalcleansers should gently cleanse the skin, cause little or no irritation,and not leave the skin overly dry after frequent use and preferablyshould provide a moisturizing benefit to the skin.

Finally, these traditional antimicrobial compositions have beendeveloped for use in a washing process with water. This limits their useto locations with available water.

Cleansing wipes have been used, in the past, to wash hands and facewhile traveling or in public or anytime water is not available. In fact,consumers have used absorbent sheets impregnated with topicalcompositions for a variety of purposes. U.S. Pat. No. 4,045,364,Richter, et al., issued Aug. 30, 1977 teaches a dry disposable paperimpregnated with a germicidal composition comprising an anionicsurfactant, an elemental iodine or iodophor active ingredient and a weakacid for pH adjustment. The compositions utilize iodine actives whichare not stable in the presence of substantial amounts of water andinsufficient acid levels to provide the improved immediate germreduction of the present invention. European Patent Application, EP 0619 074, Touchet et al., published Oct. 12, 1994, teaches the use ofsorbic or benzoic acids as antimicrobial agents in a wipe, however doesnot teach the anionic surfactant and separate antimicrobial activenecessary to achieve the residual effectiveness of the presentinvention. U.S. Pat. No. 4,975,217, Brown-Skrobot et al., issued Dec. 4,1990 teaches the use of anionic surfactants and organic acids on a wipe,however does not teach the use of the active required to provide theimproved residual effectiveness benefits.

Currently marketed Nice'n Clean®, Wash'n Dry® and No More Germies® areall antibacterial wipes which utilize harsh cationic surfactants with noadditional antibacterial active. These products do not provide theimproved immediate germ reduction and are harsh to the skin. Currentwipes have been found to give about 1.0 log reduction of germs inOne-wash tests.

PCT application WO 92/18100, Keegan et al., published Oct. 29, 1992 andPCT application WO 95/32705, Fujiwara et al., published Dec. 7, 1995teach non-wipe liquid skin cleansers comprising mild surfactants,antibacterial agents and acidic compounds to buffer the pH which provideimproved germ hostility. However, the use of the acid compounds for onlypH adjustment therein, results in compositions which do not deliver theundissociated acid required to provide the improved immediate germreduction of the present invention. This situation is compounded inKeegan and Fujiwara by the preference of mild surfactants, includingnonionic surfactants. Neither Keegan nor Fujiwara teach the use of theircompositions in a form which can be used without available water, e.g. awipe.

Hibiclens® Surgical Scrub provides 2.5 to 3.0 log reduction in germs inone wash, and U.S. Pat. No. 3,141,821, issued to Compeau Jul. 21, 1964;Irgasan DP 300 (Triclosan) ®) technical literature from Ciba-Giegy,Inc., “Basic Formulation for Hand Disinfection 89/42/01”; Bartzokas, C.A., et al, “Evaluation of the Skin Disinfecting Activity and CumulativeEffect of Chlorhexidine and Triclosan Handwash Preparations on HandsArtificially Contaminated with Serratia marcescens”, Infection Control,1987/Vol. 8, No. 4; all set forth antibacterial skin cleanserscompositions which could provide improved immediate germ reduction usingcertain anionic surfactants, antimicrobial actives and acids. However,the selection, therein, of highly active surfactants or cationic activeswith safety issues (i.e. chlorohexidine gluconate) results in personalcleansing compositions which are drying and harsh, or potentially unsafeto use.

Given the health impacts of bacteria like Staphylococcus aureus,Streptococcus pyogenes and Clostridium botulinum, it would be highlydesirable to formulate antimicrobial cleansing products which providesimproved immediate germ reduction on the skin, which are mild to theskin and which can be used without water. Existing products have beenunable to deliver all of these benefits.

Applicants have found that antimicrobial wipes which provide suchmildness and a new level of immediate germ reduction can be formulatedby using known porous or absorbent sheets which are impregnated withimproved antimicrobial cleansing compositions. These improvedantimicrobial cleansing compositions contain antibacterial actives incombination with specific organic and/or inorganic acids as protondonating agents, and specific anionic surfactants, all of which aredeposited on the skin. The deposited proton donating agent and anionicsurfactant enhance the selected active, to provide a new level ofhostility to bacteria contacting the skin.

SUMMARY OF THE INVENTION

The present invention relates to an antimicrobial wipe effective againstGram positive bacteria, Gram negative bacteria, fungi, yeasts, molds,and viruses comprising a porous or absorbent sheet impregnated with anantimicrobial cleansing composition, wherein the antimicrobial cleansingcomposition comprises from about 0.001% to about 5.0%, by weight of theantimicrobial cleansing composition, of an antimicrobial active; fromabout 0.05% to about 10%, by weight of the antimicrobial cleansingcomposition, of an anionic surfactant; from about 0.1% to about 10%, byweight of the antimicrobial cleansing composition, of a proton donatingagent; and from about 3% to about 99.85% , by weight of theantimicrobial cleansing composition, water; wherein the composition isadjusted to a pH of from about 3.0 to about 6.0; wherein theantimicrobial cleansing composition an One-wash Immediate Germ ReductionIndex of greater than about 1.3; and wherein the antimicrobial wipe hasa Mildness Index of greater than 0.3. The present invention also relatesto methods for reducing the number of germs on the skin using theantimicrobial wipes described herein.

DETAILED DESCRIPTION OF THE INVENTION

The antimicrobial wipes of the present invention are highly efficaciousfor providing a improved immediate germ reduction on the skin, are mildto the skin and can be used without additional available water.

The term “antimicrobial wipe” is used herein to mean products in which asheet of porous or absorbent material have been impregnated with anantimicrobial cleansing composition for the purpose of rubbing the wipeproduct over a surface to clean the surface and control the growth andviability of transient bacteria. The term “antimicrobial cleansingcomposition” as used herein means a composition suitable for applicationto the human skin for the purpose of removing dirt, oil and the like,which additionally controls the growth and viability of transientbacteria on the skin.

The compositions of the present invention can also be useful fortreatment of acne. As used herein “treating acne” means preventing,retarding and/or arresting the process of acne formation in mammalianskin.

The compositions of the invention can also be useful for providing anessentially immediate (i.e., acute) visual improvement in skinappearance following application of the composition to the skin. Moreparticularly, the compositions of the present invention are useful forregulating skin condition, including regulating visible and/or tactilediscontinuities in skin, including but not limited to visible and/ortactile discontinuities in skin texture and/or color, more especiallydiscontinuities associated with skin aging. Such discontinuities may beinduced or caused by internal and/or external factors. Extrinsic factorsinclude ultraviolet radiation (e.g., from sun exposure), environmentalpollution, wind, heat, low humidity, harsh surfactants, abrasives, andthe like. Intrinsic factors include chronological aging and otherbiochemical changes from within the skin.

Regulating skin condition includes prophylactically and/ortherapeutically regulating skin condition. As used herein,prophylactically regulating skin condition includes delaying, minimizingand/or preventing visible and/or tactile discontinuities in skin. Asused herein, therapeutically regulating skin condition includesameliorating, e.g., diminishing, minimizing and/or effacing, suchdiscontinuities. Regulating skin condition involves improving skinappearance and/or feel, e.g., providing a smoother, more even appearanceand/or feel. As used herein, regulating skin condition includesregulating signs of aging. “Regulating signs of skin aging” includesprophylactically regulating and/or therapeutically regulating one ormore of such signs (similarly, regulating a given sign of skin aging,e.g., lines, wrinkles or pores, includes prophylactically regulatingand/or therapeutically regulating that sign).

“Signs of skin aging” include, but are not limited to, all outwardvisibly and tactilely perceptible manifestations as well as any othermacro or micro effects due to skin aging. Such signs may be induced orcaused by intrinsic factors or extrinsic factors, e.g., chronologicalaging and/or environmental damage. These signs may result from processeswhich include, but are not limited to, the development of texturaldiscontinuities such as wrinkles, including both fine superficialwrinkles and coarse deep wrinkles, skin lines, crevices, bumps, largepores (e.g., associated with adnexal structures such as sweat glandducts, sebaceous glands, or hair follicles), scaliness, flakiness and/orother forms of skin unevenness or roughness, loss of skin elasticity(loss and/or inactivation of functional skin elastin), sagging(including puffiness in the eve area and jowls), loss of skin firmness,loss of skin tightness, loss of skin recoil from deformation,discoloration (including undereye circles), blotching, sallowness,hyperpigmented skin regions such as age spots and freckles, keratoses,abnormal differentiation, hyperkeratinization, elastosis, collagenbreakdown, and other histological changes in the stratum corneum,dermis, epidermis, the skin vascular system (e.g., telangiectasia orspider vessels), and underlying tissues, especially those proximate tothe skin.

All percentages and ratios used herein, unless otherwise indicated, areby weight and all measurements made are at 25° C., unless otherwisedesignated. The invention hereof can comprise, consist of, or consistessentially of, the essential as well as optional ingredients andcomponents described therein.

The antimicrobial wipes of the present invention comprise the followingessential components.

A. THE POROUS OR ABSORBENT SHEET

The antimicrobial cleansing composition is impregnated at the desiredweight onto one or both sides of an absorbent sheet (hereinaftersometimes referred to as “substrate”) which may be formed from any wovenor nonwoven fiber, fiber mixture or foam of sufficient wet strength andabsorbency to hold an effective amount of the antimicrobial cleansingcomposition. It is preferred from the standpoint of antimicrobialeffectiveness and mildness to employ substrates with a high absorbentcapacity (e.g., from about 5 to about 20 grams/gram, preferably fromabout 9 to about 20 grams/gram). The absorbent capacity of a substrateis the ability of the substrate, while supported horizontally, to holdliquid. The absorbent capacity of a substrate is measured according tothe Absorbent Capacity Method set forth hereinafter in the AnalyticalMethods section.

In particular, woven or nonwoven fabrics derived from “oriented” orcarded fibrous webs composed of textile-length fibers, the majorproportion of which are oriented predominantly in one direction aresuitable for use herein. These fabrics can be in the form of, forexample, wipes or towelettes, including baby wipes and the like.

Methods of making woven and nonwoven cloths are not a part of thisinvention and, being well known in the art, are not described in detailherein. Generally, however, such cloths are made by air- or water-layingprocesses in which the fibers or filaments are first cut to desiredlengths from long strands, passed into a water or air stream, and thendeposited onto a screen through which the fiber-laden air or water ispassed. The deposited fibers or filaments are then adhesively bondedtogether, and otherwise treated as desired to form the woven, nonwoven,or cellulose cloth.

Thermocarded nonwoven cloths (whether or not resin-containing) are madeof polyesters, polyamides, or other thermoplastic fibers which can bespand bonded, i.e., the fibers are spun out onto a flat surface andbonded (melted) together by heat or chemical reactions.

The nonwoven cloth substrates used in the invention herein are generallyadhesively bonded fibers or filamentous products having a web or cardedfiber structure (when the fiber strength is suitable to allow carding)or comprising fibrous mats in which the fibers or filaments aredistributed haphazardly or in random array (i.e., an array of fibers ina carded web where partial orientation of the fibers is frequentlypresent, as well as a completely haphazard distributional orientation),or substantially aligned. The fibers or filaments can be natural (e.g.,wool, silk, jute, hemp, cotton, linen, sisal, or ramie) or synthetic(e.g., rayon, cellulose ester, polyvinyl derivatives, polyolethins,polyamides, or polyesters) as have been described hereinabove. Thesenonwoven materials are generally described in Riedel “Nonwoven BondingMethods and Materials”, Nonwoven World, (1987).

The absorbent properties preferred herein are particularly easy toobtain with nonwoven cloths and are provided merely by building up thethickness of the cloth, i.e., by superimposing a plurality of cardedwebs or mats to a thickness adequate to obtain the necessary absorbentproperties, or by allowing a sufficient thickness of the fibers todeposit on the screen. Any denier of the fiber (generally up to about 15denier) can be used, inasmuch as it is the free space between each fiberthat makes the thickness of the cloth directly related to the absorbentcapacity of the cloth. Thus, any thickness necessary to obtain therequired absorbent capacity can be used.

B. THE ANTIMICROBIAL CLEANSING COMPOSITION

The absorbent sheets used in the present invention are impregnated withan antimicrobial cleansing composition. The term “antimicrobialcleansing composition” as used herein means a composition suitable forapplication to a surface for the purpose of removing dirt, oil and thelike which additionally reduces the number of germs on the surface. Thecompositions, herein, are effective against Gram positive bacteria, Gramnegative bacteria, fungi, yeasts, molds, and viruses. Preferredembodiments of the present invention are cleansing compositions suitablefor use on the human skin.

I. INGREDIENTS

The antimicrobial cleansing compositions of the wipes of the presentinvention comprise an antimicrobial active, an anionic surfactant, and aproton donating agent. These components are selected so that theefficacy and optional mildness requirements hereinafter defined for thecompositions herein are met. The selection of each component isnecessarily dependent on the selection of each of the other components.For example, if a weak acid is selected as the proton donating agent,then in order to realize an efficacious composition, either a morebiologically active (but possibly less mild) surfactant must beemployed, and/or a high level of acid within the prescribed range mustbe used and/or a particularly efficacious active must be employed.Similarly, if a mild, but nonefficacious surfactant is employed, then astronger acid and/or a high level of acid may be necessary to realize anefficacious composition. If a harsh surfactant is utilized, then amildness agent may have to be utilized. Guidelines for the selection ofthe individual components are provided herein.

The Antimicrobial Active

The antimicrobial cleansing composition of the antimicrobial wipes ofthe present invention comprises from about 0.001% to about 5%,preferably from about 0.05% to about 1%, more preferably from about0.05% to about 0.5% and more preferably from about 0.1% to about 0.25%,by weight of the antimicrobial cleansing composition, of anantimicrobial active. The exact amount of antibacterial active to beused in the compositions will depend on the particular active utilizedsince actives vary in potency. Non-cationic actives are required inorder to avoid interaction with the anionic surfactants of theinvention.

Given below are examples of non-cationic antimicrobial agents which areuseful in the present invention.

Pyrithiones, especially the zinc complex (ZPT)

Octopirox®

Dimethyldimethylol Hydantoin (Glydant®)

Methylchloroisothiazol inone/methyl isothiazolinone (Kathon CG®)

Sodium Sulfite

Sodium Bisulfite

Imidazolidinyl Urea (Germall 115®)

Diazolidinyl Urea (Germaill II®)

Benzyl Alcohol

2-Bromo-2-nitropropane-1,3-diol (Bronopol®)

Formalin (formaldehyde)

lodopropenyl Butylcarbamate (Polyphase P100®)

Chloroacetamide

Methanamine

Methyldibromonitrile Glutaronitrile (1,2-Dibromo-2,4-dicyanobutane orTektamer®)

Glutaraldehyde

5-bromo-5-nitro-1,3-dioxane (Bronidox®)

Phenethyl Alcohol

o-Phenylphenol/sodium o-phenylphenol

Sodium Hydroxymethylglycinate (Suttocide A®)

Polymethoxy Bicyclic Oxazolidine (Nuosept C®)

Dimethoxane

Thimersal

Dichlorobenzyl Alcohol

Captan

Chlorphenenesin

Dichlorophene

Chlorbutanol

Glyceryl Laurate

Halogenated Diphenyl Ethers

2,4,4′-trichloro-2′-hydroxy-diphenyl ether (Triclosan® or TCS)

2,2′-dihydroxy-5,5′-dibromo-diphenyl ether

Phenolic Compounds

Phenol

2-Methyl Phenol

3-Methyl Phenol

4-Methyl Phenol

4-Ethyl Phenol

2,4-Dimethyl Phenol

2,5-Dimethyl Phenol

3,4-Dimethyl Phenol

2,6-Dimethyl Phenol

4-n-Propyl Phenol

4-n-Butyl Phenol

4-n-Amyl Phenol

4-tert-Amyl Phenol

4-n-Hexyl Phenol

4-n-Heptyl Phenol

Mono- and Poly-Alkyl and Aromatic Halophenols

p-Chlorophenol

Methyl p-Chlorophenol

Ethyl p-Chlorophenol

n-Propyl p-Chlorophenol

n-Butyl p-Chlorophenol

n-Amyl p-Chlorophenol

sec-Amyl p-Chlorophenol

n-Hexyl p-Chlorophenol

Cyclohexyl p-Chlorophenol

n-Heptyl p-Chlorophenol

n-Octyl p-Chlorophenol

o-Chlorophenol

Methyl o-Chlorophenol

Ethyl o-Chlorophenol

n-Propyl o-Chlorophenol

n-Butyl o-Chlorophenol

n-Amyl o-Chlorophenol

tert-Amyl o-Chlorophenol

n-Hexyl o-Chlorophenol

n-Heptyl o-Chlorophenol

o-Benzyl p-Chlorophenol

o-Benxyl-m-methyl p-Chlorophenol

o-Benzyl-m, m-dimethyl p-Chlorophenol

o-Phenylethyl p-Chlorophenol

o-Phenylethyl-m-methyl p-Chlorophenol

3-Methyl p-Chlorophenol

3,5-Dimethyl p-Chlorophenol

6-Ethyl-3-methyl p-Chlorophenol

6-n-Propyl-3-methyl p-Chlorophenol

6-iso-Propyl-3-methyl p-Chlorophenol

2-Ethyl-3,5-dimethyl p-Chlorophenol

6-sec-Butyl-3-methyl p-Chlorophenol

2-iso-Propyl-3,5-dimethyl p-Chlorophenol

6-Diethylmethyl-3-methyl p-Chlorophenol

6-iso-Propyl-2-ethyl-3-methyl p-Chlorophenol

2-sec-Amyl-3,5-dimethyl p-Chlorophenol

2-Diethylmethyl-3,5-dimethyl p-Chlorophenol

6-sec-Octyl-3-methyl p-Chlorophenol

p-Chloro-m-cresol

p-Bromophenol

Methyl p-Bromophenol

Ethyl p-Bromophenol

n-Propyl p-Bromophenol

n-Butyl p-Bromophenol

n-Amyl p-Bromophenol

sec-Amyl p-Bromophenol

n-Hexyl p-Bromophenol

Cyclohexyl

p-Bromophenol

o-Bromophenol

tert-Amyl o-Bromophenol

n-Hexyl o-Bromophenol

n-Propyl-m,m-Dimethyl o-Bromophenol

2-Phenyl Phenol

4-Chloro-2-methyl phenol

4-Chloro-3-methyl phenol

4-Chloro-3,5-dimethyl phenol

2,4-Dichloro-3,5-dimethylphenol

3,4,5,6-Terabromo-2-methylphenol

5-Methyl-2-pentylphenol

4-Isopropyl-3-methylphenol

Para-chloro-meta-xylenol (PCMX)

Chlorothymol

Phenoxyethanol

Phenoxyisopropanol

5-Chloro-2-hydroxydiphenylinethane

Resorcinol and its Derivatives

Resorcinol

Methyl Resorcinol

Ethyl Resorcinol

n-Propyl Resorcinol

n-Butyl Resorcinol

n-Amyl Resorcinol

n-Hexyl Resorcinol

n-Heptyl Resorcinol

n-Octyl Resorcinol

n-Nonyl Resorcinol

Phenyl Resorcinol

Benzyl Resorcinol

Phenylethyl Resorcinol

Phenylpropyl Resorcinol

p-Chlorobenzyl Resorcinol

5-Chloro 2,4-Dihydroxydiphenyl Methane

4′-Chloro 2,4-Dihydroxydiphenyl Methane

5-Bromo 2,4-Dihydroxydiphenyl Methane

4′-Bromo 2,4-Dihydroxydiphenyl Methane

Bisphenolic Compounds

2,2′-Methylene bis (4-chlorophenol)

2,2′-Methylene bis (3,4,6-trichlorophenol)

2,2′-Methylene bis (4-chloro-6-bromophenol)

bis (2-hydroxy-3,5-dichlorophenyl) sulphide

bis (2-hydroxy-5-chlorobenzyl)sulphide

Benzoic Esters (Parabens)

Methylparaben

Propylparaben

Butylparaben

Ethylparaben

Isopropylparaben

Isobutylparaben

Benzylparaben

Sodium Methylparaben

Sodium Propylparaben

Halogenated Carbanilides

3,4,4′-Trichlorocarbanilides (Triclocarban® TCC)

3-Trifluoromethyl-4,4′-dichlorocarbanilide

3,3′,4-Trichlorocarbanilide

Another class of antibacterial agents, which are useful in the presentinvention, are the so-called “natural” antibacterial actives, referredto as natural essential oils. These actives derive their names fromtheir natural occurrence in plants. Typical natural essential oilantibacterial actives include oils of anise, lemon, orange, rosemary,wintergreen, thyme, lavender, cloves, hops, tea tree, citronella, wheat,barley, lemongrass, cedar leaf, cedarwood, cinnamon, fleagrass,geranium, sandalwood, violet, cranberry, eucalyptus, vervain,peppermint, gum benzoin, basil, fennel, fir, balsam, menthol, ocmeaoriganum, Hydastis carradensis, Berberidaceae daceae, Ratanhiae andCurcunia longa. Also included in this class of natural essential oilsare the key chemical components of the plant oils which have been foundto provide the antimicrobial benefit. These chemicals include, but arenot limited to anethol, catechole, camphene, carvacol, eugenol,eucalyptol, ferulic acid, farnesol, hinokitiol, tropolone, limonene,menthol, methyl salicylate, thymol, terpineol, verbenone, berberine,ratanhiae extract, caryophellene oxide, citronellic acid, curcumin,nerolidol and geraniol.

Additional active agents are antibacterial metal salts. This classgenerally includes salts of metals in groups 3b-7b, 8 and 3a-5a.Specifically are the salts of aluminum, zirconium, zinc, silver, gold,copper, lanthanum, tin, mercury, bismuth, selenium, strontium, scandium,yttrium, cerium, praseodymiun, neodymium, promethum, samarium, europium,gadolinium, terbium, dysprosium, holmium, erbium, thulium, ytterbium,lutetium and mixtures thereof.

Preferred antimicrobial agents for use herein are the broad spectrumactives selected from the group consisting of Triclosan®, Triclocarban®,Octopirox®, PCMX, ZPT, natural essential oils and their key ingredients,and mixtures thereof. The most preferred antimicrobial active for use inthe present invention is Triclosan®.

Anionic Surfactant

The antimicrobial cleansing compositions of the present inventioncomprise from about 0.05% to about 10%, preferably from about 0.1% toabout 2%, and more preferably from about 0.2% to about 1%, by weight ofthe cleansing composition, of an anionic surfactant. Without beinglimited by theory, it is believed that the anionic surfactant disruptsthe lipid in the cell membrane of the bacteria. The particular acid usedherein reduces the negative charges on the cell wall of the bacteria,crosses through the cell membrane, weakened by the surfactant, andacidifies the cytoplasm of the bacteria. The antimicrobial active canthen pass more easily through the weakened cell wall, and moreefficiently poison the bacteria.

Nonlimiting examples of anionic lathering surfactants useful in thecompositions of the present invention are disclosed in McCutcheon's,Detergents and Emulsifiers, North American edition (1990), published byThe Manufacturing Confectioner Publishing Co.; McCutcheon's, FunctionalMaterials, North American Edition (1992); and U.S. Pat. No. 3,929,678,to Laughlin et al., issued Dec. 30, 1975, all of which are incorporatedby reference.

A wide variety of anionic surfactants are potentially useful herein.Nonlimiting examples of anionic lathering surfactants include thoseselected from the group consisting of alkyl and alkyl ether sulfates,sulfated monoglycerides, sulfonated olefins, alkyl aryl sulfonates,primary or secondary alkane sulfonates, alkyl sulfosuccinates, acyltaurates, acyl isethionates, alkyl glycerylether sulfonate, sulfonatedmethyl esters, sulfonated fatty acids, alkyl phosphates, acylglutamates, acyl sarcosinates, alkyl sulfoacetates, acylated peptides,alkyl ether carboxylates, acyl lactylates, anionic fluorosurfactants,and mixtures thereof. Mixtures of anionic surfactants can be usedeffectively in the present invention.

Anionic surfactants for use in the cleansing compositions include alkyland alkyl ether sulfates. These materials have the respective formulaeR¹O—SO₃M and R¹(CH₂H₄O)_(x)—O—SO₃M, wherein R¹ is a saturated orunsaturated, branched or unbranched alkyl group from about 8 to about 24carbon atoms, x is 1 to 10, and M is a water-soluble cation such asammonium, sodium, potassium, magnesium, triethanolamine, diethanolamineand monoethanolamine. The alkyl sulfates are typically made by thesulfation of monohydric alcohols (having from about 8 to about 24 carbonatoms) using sulfur trioxide or other known sulfation technique. Thealkyl ether sulfates are typically made as condensation products ofethylene oxide and monohydric alcohols (having from about 8 to about 24carbon atoms) and then sulfated. These alcohols can be derived fromfats, e.g., coconut oil or tallow, or can be synthetic. Specificexamples of alkyl sulfates which may be used in the cleansercompositions are sodium, ammonium, potassium, magnesium, or TEA salts oflauryl or myristyl sulfate. Examples of alkyl ether sulfates which maybe used include ammonium, sodium, magnesium, or TEA laureth-3 sulfate.

Another suitable class of anionic surfactants are the sulfatedmonoglycerides of the form R¹CO—O—CH₂—C(OH)H—CH₂—O—SO₃M, wherein R¹ is asaturated or unsaturated, branched or unbranched alkyl group from about8 to about 24 carbon atoms, and M is a water-soluble cation such asammonium, sodium, potassium, magnesium, triethanolamine, diethanolamineand monoethanolamine. These are typically made by the reaction ofglycerin with fatty acids (having from about 8 to about 24 carbon atoms)to form a monoglyceride and the subsequent sulfation of thismonoglyceride with sulfur trioxide. An example of a sulfatedmonoglyceride is sodium cocomonoglyceride sulfate.

Other suitable anionic surfactants include olefin sulfonates of the formR¹SO₃M, wherein R¹ is a mono-olefin having from about 12 to about 24carbon atoms, and M is a water-soluble cation such as ammonium, sodium,potassium, magnesium, triethanolamine, diethanolamine andmonoethanolamine. These compounds can be produced by the sulfonation ofalpha olefins by means of uncomplexed sulfur trioxide, followed byneutralization of the acid reaction mixture in conditions such that anysultones which have been formed in the reaction are hydrolyzed to givethe corresponding hydroxyalkanesulfonate. An example of a sulfonatedolefin is sodium C₁₄/C₁₆ alpha olefin sulfonate.

Other suitable anionic surfactants are the linear alkylbenzenesulfonates of the form R¹⁻—C₆H₄—SO₃M, wherein R¹ is a saturated orunsaturated, branched or unbranched alkyl group from about 8 to about 24carbon atoms, and M is a water-soluble cation such as ammonium, sodium,potassium, magnesium, triethanolamine, diethanolamine andmonoethanolamine. These are formed by the sulfonation of linear alkylbenzene with sulfur trioxide. An example of this anionic surfactant issodium dodecylbenzene sulfonate.

Still other anionic surfactants suitable for this cleansing compositioninclude the primary or secondary alkane sulfonates of the form R¹SO₃M,wherein R¹ is a saturated or unsaturated, branched or unbranched alkylchain from about 8 to about 24 carbon atoms, and M is a water-solublecation such as ammonium, sodium, potassium, magnesium, triethanolamine,diethanolamine and monoethanolamine. These are commonly formed by thesulfonation of paraffins using sulfur dioxide in the presence ofchlorine and ultraviolet light or another known sulfonation method. Thesulfonation can occur in either the secondary or primary positions ofthe alkyl chain. An example of an alkane sulfonate useful herein isalkali metal or ammonium C₁₃-C₁₇ paraffin sulfonates.

Still other suitable anionic surfactants are the alkyl sulfosuccinates,which include disodium N-octadecylsulfosuccinamate; diammonium laurylsulfosuccinate; tetrasodiumN-(1,2-dicarboxyethyl)-N-octadecylsulfosuccinate; diamyl ester of sodiumsulfosuccinic acid; dihexyl ester of sodium sulfosuccinic acid; anddioctyl esters of sodium sulfosuccinic acid.

Also useful are taurates which are based on taurine, which is also knownas 2-aminoethanesulfonic acid. Examples of taurates includeN-alkyltaurines such as the one prepared by reacting dodecylamine withsodium isethionate according to the teaching of U.S. Pat. No. 2,658,072which is incorporated herein by reference in its entirety. Otherexamples based of taurine include the acyl taurines formed by thereaction of n-methyl taurine with fatty acids (having from about 8 toabout 24 carbon atoms).

Another class of anionic surfactants suitable for use in the cleansingcomposition are the acyl isethionates. The acyl isethionates typicallyhave the formula R¹CO—O—CH₂CH₂SO₃M wherein R¹ is a saturated orunsaturated, branched or unbranched alkyl group having from about 10 toabout 30 carbon atoms, and M is a cation. These are typically formed bythe reaction of fatty acids (having from about 8 to about 30 carbonatoms) with an alkali metal isethionate. Nonlimiting examples of theseacyl isethionates include ammonium cocoyl isethionate, sodium cocoylisethionate, sodium lauroyl isethionate, and mixtures thereof.

Still other suitable anionic surfactants are the alkylglyceryl ethersulfonates of the form R¹—OCH₂—C(OH)H—CH₂—SO₃M, wherein R¹ is asaturated or unsaturated, branched or unbranched alkyl group from about8 to about 24 carbon atoms, and M is a water-soluble cation such asammonium, sodium, potassium, magnesium, triethanolamine, diethanolamineand monoethanolamine. These can be formed by the reaction ofepichlorohydrin and sodium bisulfite with fatty alcohols (having fromabout 8 to about 24 carbon atoms) or other known methods. One example issodium cocoglyceryl ether sulfonate.

Other suitable anionic surfactants include the sulfonated fatty acids ofthe form R¹—CH(SO₄)—COOH and sulfonated methyl esters of the fromR¹—CH(SO₄)—CO—O—CH₃, where R¹ is a saturated or unsaturated, branched orunbranched alkyl group from about 8 to about 24 carbon atoms. These canbe formed by the sulfonation of fatty acids or alkyl methyl esters(having from about 8 to about 24 carbon atoms) with sulfur trioxide orby another known sulfonation technique. Examples include alphasulphonated coconut fatty acid and lauryl methyl ester.

Other anionic materials include phosphates such as monoalkyl, dialkyl,and trialkylphosphate salts formed by the reaction of phosphorouspentoxide with monohydric branched or unbranched alcohols having fromabout 8 to about 24 carbon atoms. These could also be formed by otherknown phosphation methods. An example from this class of surfactants issodium mono or dilaurylphosphate.

Other anionic materials include acyl glutamates corresponding to theformula R¹CO—N(COOH)—CH₂CH₂—CO₂M wherein R¹ is a saturated orunsaturated, branched or unbranched alkyl or alkenyl group of about 8 toabout 24 carbon atoms, and M is a water-soluble cation. Nonlimitingexamples of which include sodium lauroyl glutamate and sodium cocoylglutamate.

Other anionic materials include alkanoyl sarcosinates corresponding tothe formula R¹CON(CH₃)—CH₂CH₂—CO₂M wherein R¹ is a saturated orunsaturated, branched or unbranched alkyl or alkenyl group of about 10to about 20 carbon atoms, and M is a water-soluble cation. Nonlimitingexamples of which include sodium lauroyl sarcosinate, sodium cocoylsarcosinate, and ammonium lauroyl sarcosinate.

Other anionic materials include alkyl ether carboxylates correspondingto the formula R¹⁻—(OCH₁₂CH₂)_(x)—OCH₂—CO₂M wherein R¹ is a saturated orunsaturated, branched or unbranched alkyl or alkenyl group of about 8 toabout 24 carbon atoms, x is 1 to 10, and M is a water-soluble cation.Nonlimiting examples of which include sodium laureth carboxylate.

Other anionic materials include acyl lactylates corresponding to theformula R¹CO—[O—CH(CH₃)—CO]_(x)—CO₂M wherein R¹ is a saturated orunsaturated, branched or unbranched alkyl or alkenyl group of about 8 toabout 24 carbon atoms, x is 3, and M is a water-soluble cation.Nonlimiting, examples of which include sodium cocoyl lactylate.

Other anionic materials include the carboxylates, nonlimiting examplesof which include sodium lauroyl carboxylate, sodium cocoyl carboxylate,and ammonium lauroyl carboxylate. Anionic flourosurfactants can also beused.

Any counter cation, M, can be used on the anionic surfactant. Preferablythe counter cation is selected from the group consisting of sodium,potassium, ammonium, monoethanolamine, diethanolamine, andtriethanolamilne. More preferably the counter cation is ammonium.

Two factors must be taken into account when selecting the surfactant orsurfactants to be employed in the antibacterial cleansing compositionsof the antimicrobial wipes herein: 1) the activity of the surfactantmolecule at the cell membrane of the bacteria; and 2) the mildness ofthe surfactant insofar as it affects the Mildness Index (hereinafterdescribed) for the antibacterial composition.

Biological Activity/Mildness of Surfactant

In general, the higher the biological activity of the surfactant, themore residual effectiveness is provided by the composition comprisingthe surfactant. Typically, however, the biological activity of asurfactant and the mildness of a surfactant are inversely proportional;the higher the biological activity of the surfactant, the harsher thesurfactant and the lower the biological activity of the surfactant, themilder the surfactant. Whether a biologically active, but harshsurfactant or a mild, but biologically inactive surfactant is desiredwill, of course, depend on (or influence) the selection of the othercomponents.

The biological activity/mildness of a pure surfactant can measureddirectly via a Microtox Response Test hereinafter described in theAnalytical Methods section and can be reported as a Microtox ResponseIndex. By “pure surfactant” it is meant a chemical compositionconsisting essentially of a singale surfactant entity, wherein theentity has essentially one chain length, head group and salt counterion. From a standpoint of high biological activity, preferred anionicsurfactants of the antimicrobial cleansing compositions of the presentinvention have a Microtox Response Index of less that about 150, morepreferably less than about 100 and most preferably less than about 50.From a standpoint of mildness, preferred anionic surfactants of theantimicrobial cleansing compositions of the present invention have aMicrotox Response Index of greater than about 25, more preferablygreater than about 50 and most preferably greater than about 100.Surfactants with a Microtox Response Index ranging from about 25 toabout 150 are typically moderately biologically active and moderatelymild.

For surfactant compositions which are mixtures of surfactants ratherthan pure surfactants (this includes “commercial grade” surfactantswhich typically comprise mixtures of entities with different chainlengths and potentially have higher levels of impurities), the MicrotoxResponse Index for any individual surfactant component is not a reliablemeasurement of biological activity or mildness. In the case of mixtures,the Microtox Index of each individual component can be determined andthe weighted average used as the Index for the mixture if all theindividual components of the mixture are known. If the individualcomponents of a mixture are not known, then the primary head group andchain lengths of the surfactant mixture are better indicators ofbiological activity/mildness.

Anionic surfactants or mixtures of surfactants with a chain lengthprimarily in the range of from about 8 to about 24 carbon atoms,preferably primarily from about 10 to about 18 carbon atoms and mostpreferably primarily from about 12 to about 16 carbon atoms arepreferred from the standpoint of high biological activity. As usedherein “primarily” means at least about 50%. From a standpoint ofmildness, it is preferable to minimize C12.

From the standpoint of biological activity, it is preferred that thehead group of the anionic surfactant be less than about 15 Angstroms,preferably less than about 10 Angstroms, and more preferably less thanabout 7 Angstroms. The “head group” is defined as the hydrophilicportion (non-hydrocarbon) of the anionic surfactant, measured from thefirst polar atom to the end of the molecule. The head group size isestimated from the Van der Waals radius of the atoms and theconfiguration of the surfactant molecule. Head groups with sizes lessthan about 7 Angstroms include sulfates, sulfonates, and phosphates.From the standpoint of mildness, it is preferred that the head groupsize is greater than about 7 Angstroms, and preferably greater thanabout 10 Angstroms. Head groups with sizes greater than about 10Angstroms include ethoxylated sulfates, glyceryl ether sulfonates, andisethionates. It is believed that as the head group size increases, morestearic hindrance at the cell wall prevents disruption by the surfactantand, thus, biological activity is decreased and mildness is increased.

The mildness of a surfactant or mixture of surfactants can also bedetermined by a number of other known, conventional methods formeasuring surfactant mildness. For example, the Barrier Destruction Testset forth in T. J. Franz, J. Invest. Dermatol., 1975, 64, pp. 190-195and in U.S. Pat. No. 4,673,525 to Small et al; issued Jun. 16, 1987,both of which are herein incorporated by reference, is a way ofmeasuring mildness of surfactants. In general, the milder thesurfactant, the less skin barrier that is destroyed in the barrierdestruction test. Skin barrier destruction is measured by relativeamount of radiolabeled water which passes from the test solution throughthe skin epidermis into the physiological buffer contained in thediffusate chamber. Surfactants having a Relative Skin BarrierPenetration Value of as close to zero as possible up to about 75 areconsidered mild for purposes herein. Surfactants having a Relative SkinBarrier Penetration Value of greater than about 75 are considered harshfor purposes herein.

In order for the antimicrobial composition of the antimicrobial wipesherein to be effective, both the biological activity of the surfactantand the mildness of the surfactant and acid employed in the compositionmust be taken into account.

For example, ammonium lauryl sulfate, ALS, is very biologically active(Microtox Index=1.0). Compositions comprising ALS are capable ofproviding very effective residual antibacterial effectiveness due to itsactivity, even with lower levels of antibacterial active and protondonating agent. However, compositions containing ALS may require theaddition of co-surfactants or polymers, described herein in the OptionalIngredient Section, to achieve most preferred mildness levels for thepresent invention.

A selection of ammonium laureth-3 sulfate (Microtox=120) as a surfactantwill result in compositions which are very mild, but which would requirehigher levels of proton donating agent and antimicrobial active in orderto achieve the residual effectiveness of the present invention.

Paraffin sulfonate, a commercial grade surfactant sold under the nameHastapur SAS® from Hoechst Celanese, with a small head group and averagechain length of 15.5 is a relatively active surfactant. Compositionscomprising lower levels of active and acid can be used with higherlevels of paraffin sulfonate, where the surfactant provides a largercomponent of residual effectiveness. Alternately, compositionscomprising lower levels of paraffin sulfonate can be combined with evenhigher levels of active to achieve a mild and effective composition.

Nonlimiting examples of preferred anionic surfactants useful hereininclude those selected from the group consisting of sodium and ammoniumalkyl sulfates and ether sulfates having chain lengths of predominantly12 and 14 carbon atoms, olefin sulfates having chain lengths ofpredominantly 14 and 16 carbon atoms, and paraffin sulfonates havingchain lengths of from 13 to 17 carbon atoms, and mixtures thereof.Especially preferred for use herein is ammonium and sodium laurylsulfate, ammonium and sodium myristyl sulfate, ammonium and sodiumlaureth-1 to laureth-4 sulfate, C14-C16 olefin sulfonates, C13-C17paraffin sulfonates, and mixtures thereof.

Non-anionic surfactants of the group consisting of nonionic surfactants,cationic surfactants, amphoteric surfactants and mixtures thereof, havebeen found to actually inhibit residual effectiveness benefits. It isbelieved that these surfactants interfere with the anionic surfactantdisruption of the lipid in the cell membrane. The ratio of the amount ofthese non-anionic surfactants to the amount of anionic surfactant shouldbe less than about 1:1, preferably less than about 1:2, and morepreferably less than about 1:4.

The antimicrobial cleansing compositions of the present inventionpreferably do not comprise hydrotropic sulfonates, particularly salts ofterpenoids, or mono- or binuclear aromatic compounds such as sulfonatesof camphor, toluene, xylene, cumene and naphthene.

Proton Donating Agent

The antimicrobial cleansing compositions of the present inventioncomprise from about 0.1% to about 10%, preferably from about 0.5% toabout 8%, more preferably from about 1% to about 5%, based on the weightof the personal cleansing composition, of a proton donating agent. By“proton donating agent” it is meant any acid compound or mixturethereof, which results in undissociated acid on the skin after use.Proton donating agents can be organic acids, including polymeric acids,mineral acids or mixtures thereof.

Organic Acids

Proton donating agents which are organic acids which remain at leastpartially undissociated in the neat composition and remain so when thecompositions are diluted during washing and rinsing. These organicproton donating agents can be added directly to the composition in theacid form or can be formed by adding the conjugate base of the desiredacid and a sufficient amount of a separate acid strong enough to formthe undissociated acid from the base.

Buffering Capacity

Preferred organic proton donating agents are selected and formulatedbased on their buffer capacity and pKa. Buffer capacity is defined asthe amount of protons (weight %) available in the formulation at theproduct pH for those acid groups with pKa's less than about 6.0. Buffercapacity can be either calculated using pKa's, pH, and theconcentrations of the acids and conjugate bases, ignoring any pKagreater than 6.0, or it can be determined experimentally through asimple acid-base titration using sodium hydroxide or potassium hydroxideusing an endpoint of pH equals 6.0.

Preferred organic proton donating agents of the antibacterial cleansingcomposition herein have a buffer capacity of greater than about 0.005%,more preferably greater than about 0.01%, even more preferably greaterthan about 0.02%, and most preferably greater than about 0.04%.

Mineral Acids

Proton donating agents which are mineral acids will not remainundissociated in the neat composition and when the compositions arediluted during washing and rinsing. Despite this, it has been found thatmineral acids can be effective proton donating agents for use herein.Without being limited by theory, it is believed that the strong mineralacid, acidify the carboxylic and phosphatidyl groups in proteins of theskin cells, thereby providing in-situ undissociated acid. These protondonating agents can only be added directly to the composition in theacid form.

pH

It is critical to achieving the benefits of the invention that theundissociated acid from the proton donating agent (deposited or formedin-situ) remain on the skin in the protonated form. Therefore, the pH ofthe antimicrobial cleansing compositions of the present invention mustbe adjusted to a sufficiently low level in order to either form ordeposit substantial undissociated acid on the skin. The pH of thecompositions should be adjusted and preferably buffered to range fromabout 3.0 to about 6.0, preferably from about 3.0 to about 5.0 and morepreferably from about 3.5 to about 4.5.

A non-exclusive list of examples of organic acids which can be used asthe proton donating agent are adipic acid, tartaric acid, citric acid,maleic acid, malic acid, succinic acid, glycolic acid, glutaric acid,benzoic acid, malonic acid, salicylic acid, gluconic acid, polyacrylicacid, their salts, and mixtures thereof. A non-exclusive list ofexamples of mineral acid for use herein are hydrochloric, phosphoric,sulfuric and mixtures thereof.

Water

The antimicrobial cleansing compositions of the present inventioncomprise from about 3% to about 98.899%, preferably from about 5% toabout 98%, more preferably from about 10% to about 97.5%, and mostpreferably from about 38% to about 95.99% water.

Preferable Optional Ingredients

Mildness Enhancers

In order to achieve the mildness required of the present invention,optional ingredients to enhance the mildness to the skin can be added.These ingredients include cationic and nonionic polymers,co-surfactants, moisturizers and mixtures thereof. Polymers usefulherein include polyethylene glycols, polypropylene glycols, hydrolyzedsilk proteins, hydrolyzed milk proteins, hydrolyzed keratin proteins,guar hydroxypropyltrimonium chloride, polyquats, silicone polymers andmixtures thereof. When used, the mildness enhancing polymers comprisefrom about 0.1% to about 1%, preferably from about 0.2% to about 1.0%,and more preferably from about 0.2% to about 0.6%, by weight of theantimicrobial cleansing composition, of the composition. Co-surfactantsuseful herein include nonionic surfactants such as the Genapol® 24series of ethoxylated alcohols, POE(20) sorbitan monooleate (Tween® 80),polyethylene glycol cocoate and Pluronic® propylene oxide/ethylene oxideblock polymers, and amphoteric surfactants such as alkyl betaines, alkylsultaines, alkyl amphoacetates, alkyl amphodiacetates, alkylamphopropionates, and alkyl amphodipropionates. When used, the mildnessenhancing co-surfactants comprise from about 20% to about 70%,preferably from about 20% to about 50%, by weight of the anionicsurfactant, of the cleansing composition.

Another group of mildness enhancers are lipid skin moisturizing agentswhich provide a moisturizing benefit to the user of the cleansing wipewhen the lipophilic skin moisturizing agent is deposited to the user'sskin. When used in the antimicrobial personal cleansing compositionsherein, lipophilic skin moisturizing agents are used, they are employedat a level of about 0.1% to about 30%, preferably from about 0.2% toabout 10%, most preferably from about 0.5% to about 5% by weight of thecomposition.

In some cases, the lipophilic skin moisturizing agent can desirably bedefined in terms of its solubility parameter, as defined by Vaughan inCosmetics and Toiletries, Vol. 103, p. 47-69, October 1988. A lipophilicskin moisturizing agent having a Vaughan solubility Parameter (VSP) from5 to 10, preferably from 5.5 to 9 is suitable for use in theantimicrobial cleansing compositions herein.

A wide variety of lipid type materials and mixtures of materials aresuitable for use in the antimicrobial cleansing compositions of thepresent invention. Preferably, the lipophilic skin conditioning agent isselected from the group consisting of hydrocarbon oils and waxes,silicones, fatty acid derivatives, cholesterol, cholesterol derivatives,di- and tri-glycerides, vegetable oils, vegetable oil derivatives,liquid nondigestible oils such as those described in U.S. Pat. No.3,600,186 to Mattson; Issued Aug. 17, 1971 and U.S. Pat. Nos. 4,005,195and 4,005,196 to Jandacek et al; both issued Jan. 25, 1977, all of whichare herein incorporated by reference, or blends of liquid digestible ornondigestible oils with solid polyol polyesters such as those describedin U.S. Pat. No. 4,797,300 to Jandacek; issued Jan. 10, 1989; U.S. Pat.Nos. 5,306,514, 5,306,516 and 5,306,515 to Letton; all issued Apr. 26,1994, all of which are herein incorporated by reference, andacetoglyceride esters, alkyl esters, alkenyl esters, lanolin and itsderivatives, milk tri-glycerides, wax esters, beeswax derivatives,sterols, phospholipids and mixtures thereof. Fatty acids, fatty acidsoaps and water soluble polyols are specifically excluded from ourdefinition of a lipophilic skin moisturizing agent.

Hydrocarbon oils and waxes: Some examples are petrolatum, mineral oilmicrocrystalline waxes, polyalkenes (e.g. hydrogenated andnonhydrogenated polybutene and polydecene), paraffins, cerasin,ozokerite, polyethylene and perhydrosqualene. Blends of petrolatum andhydrogenated and nonhydrogenated high molecular weight polybuteneswherein the ratio of petrolatum to polybutene ranges from about 90:10 toabout 40:60 are also suitable for use as the lipid skin moisturizingagent in the compositions herein.

Silicone Oils: Some examples are dimethicone copolyol,dimethylpolysiloxane, diethylpolysiloxane, high molecular weightdimethicone, mixed C1-C30 alkyl polysiloxane, phenyl dimethicone,dimethiconol, and mixtures thereof. More preferred are non-volatilesilicones selected from dimethicone, dimethiconol, mixed C1-C30 alkylpolysiloxane, and mixtures thereof. Nonlimiting examples of siliconesuseful herein are described in U.S. Pat. No. 5,011,681, to Ciotti etal., issued Apr. 30, 1991, which is incorporated by reference.

Di- and tri-glycerides: Some examples are castor oil, soy bean oil,derivatized soybean oils such as maleated soy bean oil, safflower oil,cotton seed oil, corn oil, walnut oil, peanut oil, olive oil, cod liveroil, almond oil, avocado oil, palm oil and sesame oil, vegetable oilsand vegetable oil derivatives; coconut oil and derivatized coconut oil,cottonseed oil and derivatized cottonseed oil, jojoba oil, cocoa butter,and the like.

Acetoelyceride esters are used and an example is acetylatedmonoglycerides.

Lanolin and its derivatives are preferred and some examples are lanolin,lanolin oil, lanolin wax, lanolin alcohols, lanolin fatty acids,isopropyl lanolate, acetylated lanolin, acetylated lanolin alcohols,lanolin alcohol linoleate, lanolin alcohol riconoleate.

It is most preferred when at least 75% of the lipophilic skinconditioning agent is comprised of lipids selected from the groupconsisting: petrolatum, blends of petrolatum and high molecular weightpolybutene, mineral oil, liquid nondigestible oils (e.g. liquidcottonseed sucrose octaesters) or blends of liquid digestible ornondigestible oils with solid polyol polyesters (e.g. sucrose octaestersprepared from C22 fatty acids) wherein the ratio of liquid digestible ornondigestible oil to solid polyol polyester ranges from about 96:4 toabout 80:20, hydrogenated or nonhydrogenated polybutene,microcrystalline wax, polyalkene, paraffin, cerasin, ozokerite,polyethylene, perhydrosqualene; dimetlicones, alkyl siloxane,polymethylsiloxane, methylphenylpolysiloxane and mixtures thereof. Whenas blend of petrolatum and other lipids is used, the ratio of petrolatumto the other selected lipids (hydrogenated or unhydrogenated polybuteneor polydecene or mineral oil) is preferably from about 10:1 to about1:2, more preferably from about 5:1 to about 1:1.

Stabilizers

When a lipophilic skin moisturizing agent is employed as the mildnessenhancer in the antimicrobial compositions herein, a stabilizer may alsobe included at a level ranging from about 0.1% to about 10%, preferablyfrom about 0.1% to about 8%, more preferably from about 0.1% to about 5%by weight of the antimicrobial cleansing composition.

The stabilizer is used to form a crystalline stabilizing network in theliquid cleansing composition that prevents the lipophilic skinmoisturizer agent droplets from coalescing and phase splitting in theproduct. The network exhibits time dependent recovery of viscosity aftershearing (e.g., thixotropy).

The stabilizers used herein are not surfactants. The stabilizers provideimproved shelf and stress stability. Some preferred hydroxyl-containingstabilizers include 12-hydroxystearic acid, 9,10-dihydroxystearic acid,tri-9,10-dihydroxystearin and tri-12-hydroxystearin (hydrogenated castoroil is mostly tri-12-hydroxystearin). Tri-12-hydroxystearin is mostpreferred for use in the compositions herein. When these crystalline,hydroxyl-containing stabilizers are utilized in the cleansingcompositions herein, they are typically present at from about 0.1% to10%, preferably from 0.1% to 8%, more preferably from 0.1% to about 5%of the antimicrobial cleansing compositions. The stabilizer is insolublein water under ambient to near ambient conditions.

Alternatively, the stabilizer employed in the cleansing compositionsherein can comprise a polymeric thickener. When polymeric thickeners asthe stabilizer in the cleansing compositions herein, they are typicallyincluded in an amount ranging from about 0.01% to about 5%, preferablyfrom about 0.3% to about 3%, by weight of the composition. The polymericthickener is preferably an anionic, nonionic, cationic orhydrophobically modifier polymer selected from the group consisting ofcationic polysaccharides of the cationic guar gum class with molecularweights of 1,000 to 3,000,000, anionic, cationic, and nonionichomopolymers derived from acrylic and/or methacrylic acid, anionic,cationic, and nonionic cellulose resins, cationic copolymers ofdimethyldialkylammonium chloride, and acrylic acid, cationichomopolymers of dimethylalkylammonium chloride, cationic polyalklene andethoxypolyalkylene imines, polyethylene glycol of molecular weight from100,000 to 4,000,000, and mixtures thereof. Preferably, the polymer isselected from the group consisting of sodium polyacrylate, hydroxy ethylcellulose, cetyl hydroxy ethyl Cellulose, and Polyquaternium 10.

Alternatively, the stabilizer employed in the cleansing compositionsherein can comprise C10-C22 ethylene glycol fatty acid esters. C10-C22ethylene glycol fatty acid esters can also desirably be employed incombination with the polymeric thickeners hereinbefore described. Theester is preferably a diester, more preferably a C14-C18 diester, mostpreferably ethylene glycol distearate. When C10-C22 ethylene glycolfatty acid esters are utilized as the stabilizer in the personalcleansing compositions herein, they are typically present at from about3% to about 10%, preferably from about 5% to about 8%, more preferablyfrom about 6% to about 8% of the personal cleansing compositions.

Another class of stabilizer which can be employed in the antimicrobialcleansing compositions of the present invention comprises dispersedamorphous silica selected from the group consisting of fumed silica andprecipitated silica and mixtures thereof. As used herein the term“dispersed amorphous silica” refers to small, finely dividednon-crystalline silica having a mean agglomerate particle size of lessthan about 100 microns.

Fumed silica, which is also known as arced silica, is produced by thevapor phase hydrolysis of silicon tetrachloride in a hydrogen oxygenflame. It is believed that the combustion process creates siliconedioxide molecules which condense to form particles. The particlescollide, attach and sinter together. The result of this process is athree dimensional branched chain aggregate. Once the aggregate coolsbelow the fusion point of silica, which is about 1710° C., furthercollisions result in mechanical entanglement of the chains to formagglomerates. Precipitated silicas and silica gels are generally made inaqueous solution. See, Cabot Technical Data Pamphlet TD-100 entitled“CAB-O-SIL® Untreated Fumed Silica Properties and Functions”, October1993, and Cabot Technical Data Pamphlet TD-104 entitled “CAB-O-SIL®Fumed Silica in Cosmetic and Personal Care Products”, March 1992, bothof which are herein incorporated by reference.

The fumed silica preferably has a mean agglomerate particle size rangingfrom about 0.1 microns to about 100 microns, preferably from about 1micron to about 50 microns, and more preferably from about 10 microns toabout 30 microns. The agglomerates are composed of aggregates which havea mean particle size ranging from about 0.01 microns to about 15microns, preferably from about 0.05 microns to about 10 microns, morepreferably from about 0.1 microns to about 5 microns and most preferablyfrom about 0.2 microns to about 0.3 microns. The silica preferably has asurface area greater than 50 sq. m/gram, more preferably greater thanabout 130 sq. m./gram, most preferably greater than about 180 sq.m./gram.

When amorphous silicas are used as the stabilizer herein, they aretypically included in the cleansing compositions at levels ranging fromabout 0.1% to about 10%, preferably from about 0.25% to about 8%, morepreferably from about 0.5% to about 5%.

A fourth class of stabilizer which can be employed in the antimicrobialcleansing compositions of the present invention comprises dispersedsmectite clay selected from the group consisting of bentonite andhectorite and mixtures thereof. Bentonite is a colloidal aluminum claysulfate. See Merck Index, Eleventh Edition, 1989, entry 1062, p. 164,which is incorporated by reference. Hectorite is a clay containingsodium, magnesium, lithium, silicon, oxygen, hydrogen and flourine. SeeMerck Index, eleventh Edition, 1989, entry 4538, p. 729, which is hereinincorporated by reference.

When smectite clay is employed as the stabilizer in the cleansingcompositions of the present invention, it is typically included inamounts ranging from about 0.1% to about 10%, preferably from about0.25% to about 8%, more preferably from about 0.5% to about 5%.

Other known stabilizers, such as fatty acids and fatty alcohols, canalso be employed in the compositions herein. Palmitic acid and lauricacid are especially preferred for use herein.

Other Optional Ingredients

The compositions of the present invention can comprise a wide range ofoptional ingredients. The CTFA International Cosmetic IngredientDictionary, Sixth Edition, 1995, which is incorporated by referenceherein in its entirety, describes a wide variety of nonlimiting cosmeticand pharmaceutical ingredients commonly used in the skin care industry,which are suitable for use in the compositions of the present invention.Nonlimiting examples of functional classes of ingredients are describedat page 537 of this reference. Examples of these functional classesinclude: abrasives, anti-acne agents, anticaking agents, antioxidants,binders, biological additives, bulking agents, chelating agents,chemical additives, colorants, cosmetic astringents, cosmetic biocides,denaturants, drug astringents, emulsifiers, external analgesics, filmformers, fragrance components, humectants, opacifying agents,plasticizers, preservatives, propellants, reducing agents, skinbleaching agents, skin-conditioning agents (emollient, humectants,miscellaneous, and occlusive), skin protectants, solvents, foamboosters, hydrotropes, solubilizing agents, suspending agents(nonsurfactant), sunscreen agents, ultraviolet light absorbers, andviscosity increasing agents (aqueous and nonaqueous). Examples of otherfunctional classes of materials useful herein that are well known to oneof ordinary skill in the art include solubilizing agents, sequestrants,and keratolytics, and the like.

II. CHARACTERISTICS

The antimicrobial wipes herein, have the following characteristics.

Immediate Germ Reduction Indexes

The antimicrobial wipes provide improved immediate reduction of germs onthe skin. The degree of reduction can be measured after one-wash of theIn-Vivo Health Care Personal Handwash Test described herein. Whenmeasured after one wash (application) the antimicrobial wipe hasOne-wash Immediate Germ Reduction Index of greater than about 1.3 (95%reduction), preferably greater than about 1.7 (98% reduction), morepreferably greater than about 2.0 (99% reduction), and most preferablygreater than about 2.3 (99.5% reduction). The index represents adifference in base ten logarithm values of bacterial concentrationsbetween before and after washing. For example, an index of 1.3represents a reduction in log values of 1.3 (Δlog=1.3) which in turnrepresents a 95% reduction of bacteria counts.

Mildness Index

The antimicrobial wipes of the present invention comprise a MildnessIndex of greater than about 0.3, preferably greater than about 0.4, andmore preferably greater than about 0.6. The Mildness Index is measuredby the Forearm Controlled Application Test (FCAT) described herein.

III. PREPARATION OF THE ABSORBENT SHEETS IMPREGNATED WITH ANTIMICROBIALCLEANSING COMPOSITION

Any method suitable for the application of aqueous or aqueous/alcoholicimpregnates, including flood coating, spray coating or metered dosing,can be used to impregnate the fibrous webs herein with the antimicrobialcleansing compositions described herein. More specialized techniques,such as Meyer Rod, floating knife or doctor blade, which are typicallyused to impregnate liquids into absorbent sheets may also be used.

The emulsion should preferably comprise from about 100% to about 400%,preferably from about 200% to about 400% by weight of the absorbentsheet.

After coating, the sheets may be folded into stacks and packaged in anyof the moisture and vapor impermeable packages known in the art.

The anti-microbial cleansing compositions of the present invention aremade via art recognized techniques for the various forms compositions.

IV. METHODS OF USING THE ANTIMICROBIAL WIPES

The antimicrobial wipe of the present invention are useful for personalcleansing, reducing germs on skin, and providing residual effectivenessGram negative and Gram positive bacteria, especially on the hands andface. Typically the wipe is used to apply cleansing compositions to thearea to be cleansed. The wipes herein can be used for personal cleansingwhen the use of cleansing products requiring water cannot be, or areinconvenient. Typical quantities of the present wipes useful forcleansing, range from about 1 to about 4 wipes per use, preferably fromabout 1 to about 2 wipes per use. Typical amounts of antimicrobialcleansing composition used range from about 4 mg/cm² to about 6 mg/cm²,preferably about 5 mg/cm² of skin area to be cleansed.

ANALYTICAL TEST METHODS

MICROTOX RESPONSE TEST

Reference: Microtox Manual: A Toxicity Testing Handbook, 1992 VolumeI-IV; Microbics Corporation.

Equipment: Microtox M500 Toxicity Testing Unit; Microbics CorporationConnected to computer for data acquisition and analysis according toabove reference.

Procedure:

1 Preparation of Sample Stock Solution (Standard Concentration: 1000ppm)

The stock solution of the test anionic surfactant sample is prepared andused as a stock solution from which all other dilutions are made. Thestandard “starting concentration”, the highest concentration to betested, is 500 ppm. (If a 500 ppm starting concentration fails to give acalculable result, e.g. an active surfactant kills all reagent at alldilutions, the starting concentration can be adjusted based on a knownrange of EC50 values of previously tested surfactants.) The stocksolution is prepared at two times the starting concentration.

a) Add 0.1 g (or adjusted amount if required) of anionic surfactant,accounting for activity of raw material, to beaker.

b) Microtox Diluent (2% NaCl, Microbics Corp.) is added to total 100 g.

c) Stir solution to make sure of adequate mixing.

2. Reconstitution of Microtox Reagent and Preparation of Assay

a) Turn on test unit and allow reagent well temperature to equilibrateat 5.5° C. and incubator block and read well temperature to equilibrateat 15° C.

b) Place a clean cuvette (Microbics Corp.) in the reagent well, and fillwith 1.0 ml of Microtox Reconstitution Solution (distilled water,Microbics, Corp.). Allow to cool for 15 minutes.

c) Reconstitute standard vial of Microtox Acute Toxicity Reagent (Vibriofischerio, Microbics Corp.) by quickly adding the 1.0 ml of the cooledreconstitution solution to the reagent vial.

d) Swirl solution in the reagent vial for 2-3 seconds then pourreconstituted reagent back into the cooled cuvette and return the vialto the reagent well. Allow to stabilize for 15 minutes.

e) Place 8 cuvettes containing 500 μl of Microtox Diluent, as assay,into the incubator wells of the test unit. Let cool for 15 minutes.

3. Test Substance Dilution

Prepare 7 serial dilutions of the test substance from the sample stocksolution. The final volume of all cuvettes must be 1.0 ml.

a) Place 8 empty cuvettes into a test tube rack.

b) Add 1.0 ml of Microtox Diluent solution to tubes 1-7.

c) Add 2.0 ml of the sample stock solution (1000 ppm) in cuvette 8.

d) Transfer 1.0 ml solution from cuvette 8 to cuvette 7 and mix cuvette7.

e) Serially transfer 1.0 ml from the newly formed solution to thesubsequent cuvette (7 to 6, 6 to 5 etc.). Remove 1.0 ml of solution fromcuvette 2 and discard. Cuvette 1 is the blank containing only MicrotoxDiluent. Place the cuvettes into the test unit incubation wells keepingthem in order of lowest to highest concentration. These cuvettes shouldcorrespond with the 8 cuvettes prepared in step 2 above. Allow to coolfor 15 minutes.

4. Assay and Sample Bioluminescence Testino

a) Add 10 μl of reconstituted reagent to the 8 precooled cuvettes ofassay prepared in step 2 above (containing 500 μl of diluent). Allow 15minutes for reagent to stabilize.

b) Start Microtox Data Capture and Reporting Software (Microbics Corp.),select START TESTING, input file name and description, correct startingconcentration in ppm (500 if standard concentration is used) and numberof controls (1) and dilutions (7). Time 1 should be selected as 5minutes, time 2 is NONE. Press enter then the space bar to begintesting.

c) Place the assay cuvette containing reagent which corresponds to thetest blank into the read well and press SET. After the cuvette hasresurfaced press READ and the value will be captured by the computer.

d) Similarly read the remaining 7 cuvettes containing reagent whenprompted by the computer by pressing the READ button with the correctcuvette in the READ well.

e) After all 8 initial reading have been taken, transfer 500 μl of thediluted test substance into their corresponding cuvette containing thereagent. Mix by vortexing or swirling and return to the incubationwells. The computer will count for five minutes and prompt you to beginfinal readings.

f) Take final readings by placing the correct cuvette containing reagentand diluted test surfactant into the read well and pressing READ whenprompted by the computer.

5. Data Analysis

The concentration of test substance, in ppm, that decreases thebioluminescence of the Microtox Acute Toxicity Reagent by 50% from thestarting value (EC50 Value) can be calculated using the Run Statisticson Data File option of the Microtox Software (recommended) or byconducting a linear regression of the data (% reduction vs. log ofconcentration). % Reductions are calculated using the followingformulas:$\frac{{Final}\quad {Reading}\quad {of}\quad {Reagent}\quad {Blank}}{{Initial}\quad {Reading}\quad {of}\quad {Reagent}\quad {Blank}} = \text{Correction~~Factor}$$\frac{{Final}\quad {Reading}\quad {of}\quad {Reagent}\quad {with}\quad {Diluted}\quad {Test}\quad {Substance}}{{Initial}\quad {Reading}\quad {of}\quad {Reagent}\quad {with}\quad {Diluted}\quad {Test}\quad {Substance}} = {{Reduction}\quad {Factor}_{x}}$where  x  means  at    a  corresponding  concentration${\% \quad {Reduction}} = \frac{{{Correction}\quad {Factor}_{x}} - {{Reduction}\quad {Factor}}}{{Correction}\quad {Factor}}$

The Microtox Index is the EC50 value in ppm.

IN-VIVO HEALTH CARE PERSONAL HANDWASH TEST (HCPHWT)

Reference: Annual Book of ASTM Standards Vol. 11.05; ASTM Designation: E1174-94; “Standard Test Method for Evaluation of Health Care PersonnelHandwash Formulation”

1. The test method used is identical to the method explained in thisreference with the following changes/clarifications.

a. Testing on a subject was finished after the one wash extraction, whenonly one-wash data was desired. The test requires at least four subjectsto be valid.

b. Historical Data was used as a control in this protocol. (i.e. acontrol soap was not run in every test)

c. Test Materials

Organism: Serratia marcescens ATCC 14756 (incubated 18-24 hrs. at 25 C.in soybean casein broth, adjusted to ˜10⁸ organisms/ml by diluting to0.45 transmittance with a spectrophotometer)

Dilution Fluid: phosphate buffer (0.1% Triton X-100, 00.3% Lecithin,1.5% Tween 80) adjusted to pH 7.2 with 1 N HCl

Agar: Soybean casein agar with 1.5% polysorbate 80

d. Application Procedure

Laboratory technical places wipe in subject's hand. Subject then wipeshis/her entire hand with wipe for fifteen (15) seconds, wiping palm,back of hand, fingers and web areas between fingers, cuticles, and nailbeds. Repeat the process for wiping of other hand. Discard wipe. Handsare not dried.

e. Bacteria were enumerated by performing serial dilutions (1:10) ofinoculum or extracted samples and spreading 0.1 ml of dilution onplates. Results are reported as the log reduction of bacteria frombaseline.

One-wash Immediate Germ Reduction Index=Log (CFU's) in BaselineExtraction−Log (CFU's) in Post−One Wash Extraction

Ten-wash Immediate Germ Reduction Index=Log (CFU's) in BaselineExtraction−Log (CFU's) in Post−Ten Wash Extraction

f. Hands were decontaminated by submersion in 70% ethanol for 15 sec.and then a five minute wash with control soap and water.

FOREARM CONTROLLED APPLICATION TEST (FCAT)

Reference: Ertel, K. D., et al.; “A Forearm Controlled ApplicationTechnique for Estimating the Relative Mildness of Personal CleansingProducts”; J. Soc. Cosmet. Chem. 46 (1995) 67-76.

The Forearm Controlled Application Test, or FCAT, is a comparative testwhich discriminates differences in product mildness to the skin. A testproduct is compared to a standard soap based cleansing bar control.

Test Group Restrictions

Test groups of 20-30 subjects, 18 to 55 years of age, who regularly washwith soap are used. Potential subjects who (1) have an initial drynessgrade of 3.0 or higher on the forearms as assessed during the initialexamination, (2) have skin cancer, eczema, or psoriasis on the forearms,(3) are receiving injectable insulin, (4) are pregnant or lactating, or(5) are receiving treatment for skin problems or contact allergy areexcluded. Subjects are to avoid hot tubs, swimming, and sun lamps, andto refrain from applying any soaps, cleansing products, creams, or gelsto their forearms for the duration of the study. Subjects are to keepwater off their forearms for at least two hours before the gradingprocess. The studies are executed using a blinded, random product orderformat. Clinical assistant should verify the correct treatment sequenceand document such before washing each subject.

Products are applied to the forearms a total of nine (9) times: two (2)times each day on the first four (4) days of the study and one (1) timeon the final day. Visits to the test facility for washing must be spacedby a minimum of three (3) hours.

All clinical assistants must wear disposable gloves during washprocedure, rinsing them between treatments, and changing betweensubjects.

Control Product

The control product is a rolled bar soap containing:

56.1% Sodium Tallowate 18.7% Sodium Cocoate 0.7% Sodium Chloride 24%Water 0.5% Minors (Perfume, Impurities)

Product Application Procedure

Both test and control products are tested on the same arm. The followingtest procedure is used.

1. The subject wets the entire surface of his/her volar forearm with95-100° F. tap water by holding the arm briefly under running tap water.

2. A clinical assistant wets one-quarter sheet (approximately 8″×6″) ofMasslinn® towel with tap water, then squeezes the towel gently to removeexcess water.

3. A clinical assistant applies the products to the arm, beginning withthe product designated for the site nearest the elbow, using theappropriate procedure as follows:

Liquid Product

a. Dispense 0.10 cc of test product from a syringe into the center ofthe appropriate marked area.

b. Wet two finders of gloved (latex) hand under the running tap (indexand middle fingers).

c. Move wetted fingers in a circular motion over the application sitefor 10 seconds to lather product.

d. Lather remains on the application site for 90 seconds, then is rinsedoff with running tap water for 15 seconds, taking care not to washlather off the adjacent sites. After 10 seconds of the rinse hasexpired, the Clinical Assistant will gently rub the site being rinsedwith her two gloved fingers for the remaining 5 seconds of the rinse.

Bar Product

a. Wet two finders of gloved (latex) hand under the running tap (indexand middle fingers).

b. Wet bar by holding bar briefly under running tap water. Test barsmust be wet under a running tap at the start of each day.

c. Rub wetted fingers in a circular motion, over the surface of the bar,for 15 seconds to form lather on bar and fingers.

d. Rub the lathered fingers on the application site in a circular motionfor 10seconds to lather product on the skin.

e. Lather remains on the application site for 90 seconds, then is rinsedoff with running tap water for 15 seconds, taking care not to washlather off the adjacent sites. After 10 seconds of the rinse hasexpired, the Clinical Assistant will gently rub the site being rinsedwith her two gloved fingers for the remaining 5 seconds of the rinse.

Wipe Products

a. Fold wipe in half, crosswise, and gently rub the wipe in a curricularmotion within the appropriate area.

b. Allow site to air dry for 90 seconds. Do not rinse site.

Leave-on Product

a. Dispense 0.10 cc of test product from a syringe into the center ofthe appropriate marked area.

b. Move gloved fingers in a circular motion over the application sitefor 10 seconds.

c. Allow site to air dry for 90 seconds. Do not rinse site.

4. While waiting for the 90 second residence time to expire, the aboveprocedure will be repeated on the remaining application site on thatarm, working down the arm toward the wrist.

5. Steps 1-4 are repeated on the appropriate test areas so twoapplications of product are made to test areas.

6. After all of the application areas have two applications of products,the clinical assistant gently pats the subject's arm dry with adisposable paper towel.

Evaluation

The skin on each treatment area is evaluated by an expert grader atbaseline and three hours after the final study wash. The treatment areasare evaluated under 2.75×magnification (model KFM-1A Luxo IlluminatedMagnifying Lamp, Marshall Industries, Dayton, Ohio) with controlledlighting (General Electric Cool White, 22-watt, 8″ Circuline fluorescentbulb).

The skin is evaluated by an expert grader, for dryness and a rating isassigned based on the definitions set forth below.

TABLE 1 Forearm Grading Scale Rating Skin Dryness 0   No dryness 1.0Patches of slight powderiness and occasional patches of small scales maybe seen. 2.0 Generalized slight powderiness. Early cracking oroccasional small lifting scales may be present. 3.0 Generalized moderatepowderiness and/or heavy cracking and lifting scales. 4.0 Generalizedheavy powderiness and/or heavy cracking and lifting scales. 5.0Generalized high cracking and lifting scales. Eczematous change may bepresent. Powderiness may be present but not prominent. May see bleedingcrack. 6.0 Generalized severe cracking. Eczematous change may bepresent. Bleeding cracks may be present. Scales large, may be beginningto disappear.

The FCAT generally produces only mild to moderate skin irritation;however, if a treated site reaches a rating of 5.0 or greater, at anytime during the study, treatment of all sites on that subject should bediscontinued.

Data

After all subjects have been evaluated at the end of the test, thefollowing values are determined:

Rc_(o)=The average rating of control product area at baseline

Rc_(f)=The average rating of control product area at test end

Rt_(o)=The average ratting of test product area at baseline

Rt_(f)=The average rating if test product area at test end.

There are many external conditions which could influence the FCAT, suchas relative humidity and water softness. The test is valid only ifsufficient response is observed in the skin to the control product. Thecontrol response must be greater than 1.0 (i.e., Rc_(f)−Rc_(o)≧1.0) forthe test to be valid.

Given a valid test, the Mildness Index of the test product is thedifference in the skin responses to two products.

Mildness Index=(Rc_(f)−Rc_(o))−(Rt_(f)−Rt_(o))

CONSISTENCY (k) AND SHEAR INDEX (n) OF THE LIPOPHILIC SKIN MOISTURIZINGAGENT

The Carrimed CSL 100 Controlled Stress Rheometer is used to determineShear Index, n, and Consistency, k, of the lipophilic skin moisturizingagent used herein. The determination is performed at 35° C. with the 4cm 2° cone measuring system typically set with a 51 micron gap and isperformed via the programmed application of a shear stress (typicallyfrom about 0.06 dynes/sq. cm to about 5,000 dynes/sq. cm) over time. Ifthis stress results in a deformation of the sample, i.e. strain of themeasuring geometry of at least 10-4 rad/sec, then this rate of strain isreported as a shear rate. These data are used to create a viscosity μVs. shear rate γ′ flow curve for the material. This flow curve can thenbe modeled in order to provide a mathematical expression that describesthe material's behavior within specific limits of shear stress and shearrate. These results were fitted with the following well accepted powerlaw model (see for instance: Chemical Engineering, by Coulson andRichardson, Pergamon, 1982 or Transport Phenomena by Bird, Stewart andLightfoot, Wiley, 1960):

Viscosity, μ=k(γ′)^(n−1)

VISCOSITY OF THE ANTIMICROBIAL CLEANSING COMPOSITION

The Wells-Brookfield Cone/Plate Model DV-II+Viscometer is used todetermine the viscosity of the antimicrobial cleansing compositionsherein. The determination is performed at 25° C. with the 2.4 cm° cone(Spindle CP-41) measuring system with a gap of 0.013 mm between the twosmall pins on the respective cone and plate. The measurement isperformed by injecting 0.5 ml of the sample to be analyzed between thecone and plate and rotating the cone at a set speed of 1 rpm. Theresistance to the rotation of the cone produces a torque that isproportional to the shear stress of the liquid sample. The amount oftorque is read and computed by the viscometer into absolute centipoiseunits (mPa's) based on geometric constants of the cone, the rate ofrotation, and the stress related torque.

ABSORBENT CAPACITY

Substrate samples are placed in a temperature and relativehumidity-controlled location for at least 2 hours prior to testing(temperature=73° F.±2° F., relative humidity 50%±2%).

A full size substrate sheet is supported horizontally in a taredfilament lined basket and weighed to provide the weight of the drysheet. The filament lined basket has crossed filaments which serve tosupport the sheet horizontally. The crossed filaments permitunrestricted movement of water into and out of the substrate sheet.

The substrate sheet, still supported in the basket, is lowered into adistilled water bath having a temperature of 73° F.±2° F. for oneminute. The basket is then raised from the bath and the substrate sheetis allowed to drain for 1 minute. The basket and sheet are thenre-weighed to obtain the weight of the water absorbed by the substratesheet.

The Absorbent Capacity, in grams/gram, is calculated by dividing theweight of the water absorbed by the sheet by the weight of the drysheet. the Absorbent Capacity is reported as an average of at least 8measurements.

EXAMPLES

The following examples further describe and demonstrate embodimentswithin the scope of the present invention. In the following examples,all ingredients are listed at an active level. The examples are givensolely for the purpose of illustration and are not to be construed aslimitations of the present invention, as many variations thereof arepossible without departing from the spirit and scope of the invention.

Ingredients are identified by chemical or CTFA name.

Fifteen antimicrobial cleansing compositions are prepared according tothe tables below.

Antimicrobial Cleansing Compositions Component Ex. 1 Ex. 2 Ex. 3 Ex. 4Ex. 5 Mineral oil 1.00% 1.00% 1.00% 1.00% 0.00% Propylene glycol 1.00%1.00% 1.00% 1.00% 1.00% Ammonium Lauryl 0.60% 0.60% 0.60% 0.60% 0.60%Sulfate Citric Acid 4.00% 0.00% 0.00% 0.00% 0.00% Sodium Citrate 3.30%0.00% 2.00% 0.00% 0.00% Succinic Acid 0.00% 4.00% 0.00% 0.00% 4.00%Sodium Succinate 0.00% 3.30% 0.00% 0.00% 3.20% Malic Acid 0.00% 0.00%2.50% 0.00% 0.00% Malonic Acid 0.00% 0.00% 0.00% 4.00% 0.00% SodiumMalonate 0.00% 0.00% 0.00% 3.20% 0.00% Steareth 20 0.55% 0.55% 0.55%0.55% 0.00% Steareth 2 0.45% 0.45% 0.45% 0.45% 0.00% Triclosan ® 0.15%0.15% 0.15% 0.15% 0.15% Miscellaneous 0.36% 0.36% 0.36% 0.36% 0.36%Water q.s. q.s. q.s. q.s. q.s. pH 4.0 4.5 3.9 3.9 3.9 Microtox ofAnionic 1 1 1 1 1 Surfactant Head Group Size of Small Small Small SmallSmall Anionic Surfactant Primary Chain Length 12 12 12 12 12 of AnionicSurfactant Component Ex. 6 Ex. 7 Ex. 8 Ex. 9 Ex. 10 Mineral oil 0.00%0.00% 1.00% 1.00% 1.00% Propylene glycol 1.00% 1.00% 1.00% 1.00% 1.00%Ammonium Lauryl 0.60% 0.60% 0.60% 0.60% 1.00% Sulfate Citric Acid 0.00%0.00% 2.50% 2.50% 4.00% Sodium Citrate 0.00% 3.70% 2.00% 2.00% 3.20%Succinic Acid 4.00% 0.00% 0.00% 0.00% 0.00% Sodium Succinate 3.00% 0.00%0.00% 0.00% 0.00% Malic Acid 0.00% 4.00% 0.00% 0.00% 0.00% Steareth 200.55% 0.00% 0.55% 0.08% 0.28% Steareth 2 0.45% 0.00% 0.45% 0.07% 0.23%Oleth 20 0.00% 0.00% 0.00% 0.08% 0.28% Oleth 2 0.00% 0.00% 0.00% 0.07%0.23% Triclosan ® 0.00% 0.50% 0.50% 0.15% 0.25% Thymol 1.00% 0.00% 0.00%0.00% 0.00% Miscellaneous 0.36% 0.36% 0.36% 0.36% 0.36% Water q.s. q.s.q.s. q.s. q.s. pH 3.2 5.0 3.9 3.9 3.9 Microtox of Anionic 1 1 1 1Surfactant Head Group Size of Small Small Small Small Small AnionicSurfactant Primary Chain Length 12 12 12 12 12 of Anionic SurfactantComponent Ex. 11 Ex. 12 Ex. 13 Ex. 14 Ex. 15 Mineral oil 1.00% 1.00%1.00% 1.00% 1.00% Propylene glycol 1.00% 1.00% 1.00% 1.00% 1.00%Ammonium Lauryl 0.00% 0.00% 0.00% 0.00% 0.60% Sulfate Ammonium Laureth0.00% 5.00% 0.00% 0.00% 0.00% Sulfate Hostapur SAS 60 (SPS) 1.00% 0.00%0.00% 0.00% 0.00% C₁₄-C₁₆ Sodium 0.00% 0.00% 2.00% 0.00% 0.00% AlphaOlefin Sulfonate Sodium Lauroyl 0.00% 0.00% 0.00% 1.00% 0.00%Sarcosinate Citric Acid 0.055% 7.50% 0.00% 0.00% 0.00% Sodium Citrate0.00% 4.00% 2.00% 0.00% 0.00% Succinic Acid 4.00% 0.00% 0.00% 0.00%0.00% Sodium Succinate 0.67% 0.00% 0.00% 0.00% 0.00% Malic Acid 0.00%0.00% 2.50% 0.00% 0.00% Malonic Acid 0.00% 0.00% 0.00% 4.00% 0.00%Sodium Malonate 0.00% 0.00% 0.00% 3.20% 0.00% Salicylic Acid 0.00% 0.00%0.00% 0.00% 0.50% Steareth 20 0.55% 0.55% 0.55% 0.55% 0.55% Steareth 20.45% 0.45% 0.45% 0.45% 0.45% Triclosan ® 0.15% 3.00% 0.15% 0.01% 0.15%Cocamidopropyl Betaine 0.00% 0.00% 0.00% 4.00% 0.00% Polyquat 10 0.00%0.00% 0.00% 0.40% 0.00% Miscellaneous 0.36% 0.36% 0.36% 0.36% 0.36%Water q.s. q.s. q.s. q.s. q.s. pH 3-6 3-6 3-6 3-6 3-6 Microtox ofAnionic n/a 150 26 <15 1 Surfactant Head Group Size Small Large SmallLarge Small of Anionic Surfactant Primary Chain Length 15.5 12 14-16 1212 of Anionic Surfactant

The antimicrobial cleansing compositions shown all have a One-washImmediate Germ Reduction Index of greater than about 1.3 and a MildnessIndex of greater than 0.3.

Procedure for Making Antimicrobial Cleansing Composition Examples

When mineral oil is used, premix mineral oil, propylene glycol, active,steareth 2 and 20, oleth 2 and 20, and 50%, by weight of the oil,glycol, active, steareth and oleth materials, water to a premix vessel.Heat to 165° F.±10° F. Add additional 50%, by weight of the oil, glycol,active, steareth and oleth materials, of water to the premix tank.

Add all but 5 weight percent of remaining water to second mix tank. Ifrequired, add premix to the mix tank. Add surfactants to mix tank. Heatmaterials to 155° F.±10° F. and mix until dissolved. Cool to less than100° F., add acid and antibacterial active, if not in premix, andperfumes. Mix until materials are dissolved. Adjust pH to target withrequired buffer (NaOH or buffer salt). Add remaining water to completeproduct.

Procedure for Making Antimicrobial Wipe Examples Compositions 1-15 areimpregnated onto absorbent sheets as follows:

Composition 1-15 are impregnated onto a wet and air laid woven absorbentsheet comprised of 85% cellulose and 15% polyester at 260% by weight ofthe absorbent sheet by pouring the composition onto the sheet via a cup.

Composition 1-15 are impregnated onto a wet and air laid woven absorbentsheet comprised of 100% cellulose at 260% by weight of the sheet bypouring the composition onto the sheet via a cup.

Compositions 1-15 are impregnated onto separate wet and air laidnonwoven absorbent sheets comprised of 50% cellulose and 50% polyesterat 260% by weight of the sheet by pouring the compositions onto thesheets via a cup.

What is claimed is:
 1. An antimicrobial wipe effective against Grampositive bacteria, Gram negative bacteria, fungi, yeasts, molds, andviruses comprising a porous or absorbent sheet impregnated with anantimicrobial cleansing composition, wherein the antimicrobial cleansingcomposition comprises the following individual components: a. from about0.001% to about 5.0%, by weight of the antimicrobial cleansingcomposition, of an antimicrobial active; b. from about 0.05% to about10%, by weight of the antimicrobial cleansing composition, of an anionicsurfactant; c. from about 0.1% to about 10%, by weight of theantimicrobial cleansing composition, of a proton donating agent; and d.from about 3% to about 99.85%, by weight of the antimicrobial cleansingcomposition, water; wherein the composition is adjusted to a pH of fromabout 3.0 to about 6.0; wherein the antimicrobial cleansing compositionexhibits a One-wash Immediate Germ Reduction Index of greater than about1.3; and wherein the antimicrobial cleansing composition has a MildnessIndex of greater than 0.3.
 2. An antimicrobial wipe according to claim 1wherein the antimicrobial active is selected from the group consistingof triclosan, triclocarban, piroctone olamine, PCMX, ZPT, naturalessential oils and their key ingredients, and mixtures thereof.
 3. Anantimicrobial wipe according to claim 2 wherein the antimicrobial activeis triclosan.
 4. An antimicrobial wipe according to claim 2 wherein theanionic surfactant has a Microtox Response Index of less than about 150.5. An antimicrobial wipe according to claim 2 wherein the protondonating agent is an organic acid having a Buffering Capacity of greaterthan about 0.005.
 6. An antimicrobial wipe according to claim 2 whereinthe proton donating agent is a mineral acid.
 7. An antimicrobial wipeaccording to claim 5 wherein the composition is adjusted to a pH of fromabout 3.5 to about 5.0.
 8. An antimicrobial wipe according to claim 7wherein the ratio of the amount of non-anionic surfactants to the amountof anionic surfactant in the antimicrobial cleansing composition is lessthan 1:1.
 9. An antimicrobial wipe effective against Gram positivebacteria, Gram negative bacteria, fungi, yeasts, molds, and virusescomprising a porous or absorbent sheet impregnated with an antimicrobialcleansing composition, wherein the antimicrobial cleansing compositioncomprises the following individual components: a. from about 0.05% toabout 1.0%, by weight of the antimicrobial cleansing composition, of anantimicrobial active; b. from about 0.1% to about 2%, by weight of theantimicrobial cleansing composition, of an anionic surfactant; c. fromabout 0.5% to about 8%, by weight of the antimicrobial cleansingcomposition, of a proton donating agent; and d. from about 3% to about99.85%, by weight of the antimicrobial cleansing composition, water;wherein the composition is adjusted to a pH of from about 3.0 to about6.0; wherein the antimicrobial cleansing composition exhibits a One-washImmediate Germ Reduction Index of greater than about 1.7; and whereinthe antimicrobial composition has a Mildness Index of greater than 0.4.10. An antimicrobial wipe according to claim 9 wherein the antimicrobialactive is selected from the group consisting of triclosan, triclocarban,piroctone olamine, PCMX, ZPT, natural essential oils and their keyingredients, and mixtures thereof.
 11. An antimicrobial wipe accordingto claim 10 wherein the antimicrobial active is triclosan.
 12. Anantimicrobial wipe according to claim 10 wherein the anionic surfactanthas a Microtox Response Index of less than about
 150. 13. Anantimicrobial wipe according to claim 10 wherein the proton donatingagent is an organic acid having a Buffering Capacity of greater thanabout 0.005.
 14. An antimicrobial wipe according to claim 10 wherein theproton donating agent is a mineral acid.
 15. An antimicrobial wipeaccording to claim 13 wherein the composition is adjusted to a pH offrom about 3.5 to about 5.0.
 16. An antimicrobial wipe according toclaim 15 wherein the ratio of the amount of non-anionic surfactants tothe amount of anionic surfactant in the antimicrobial cleansingcomposition is less than 1:1.
 17. An antimicrobial wipe according toclaim 16 which further comprises from about 1% to about 30%, by weightof the antimicrobial cleansing composition, of a lipophilic skinmoisturizing agent.
 18. A method for providing improved immediatereduction of germs on the skin comprising rubbing the antimicrobial wipeof claim 1 on human skin, wherein the antimicrobial cleansingcomposition is applied to the skin in a safe and effective amount.
 19. Amethod for providing improved immediate reduction of germs on the skin,comprising rubbing the antimicrobial wipe of claim 9 on human skin,wherein the antimicrobial cleansing composition is applied to the skinin a safe and effective amount.
 20. A method for treating acne,comprising rubbing the antimicrobial wipe of claim 1 on human skin,wherein the antimicrobial cleansing composition is applied to the skinin a safe and effective amount.
 21. An antimicrobial wipe according toclaim 1 wherein the antimicrobial cleansing composition comprises fromabout 0.05% to about 5%, by weight of the antimicrobial cleansingcomposition, of the anionic surfactant.
 22. An antimicrobial wipeaccording to claim 1 wherein the antimicrobial cleansing compositioncomprises from about 0.05% to about 2%, by weight of the antimicrobialcleansing composition, of the anionic surfactant.
 23. An antimicrobialwipe according to claim 1 wherein the ratio of the amount of non-anionicsurfactants to the amount of anionic surfactant in the antimicrobialcleansing composition is less than 1:2.
 24. An antimicrobial wipeaccording to claim 1 wherein the ratio of the amount of non-anionicsurfactants to the amount of anionic surfactant in the antimicrobialcleansing composition is less than 1:4.